Cognitive Behavioral Therapy for Irritable Bowel Syndrome

(U54_P3_CBT Trial)

Overseen By Regan Cortessis

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Narcotics, Opioids, Systemic steroids, others

Disqualifiers: Obesity, Major psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8-10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cognitive Behavioral Therapy (CBT) can help treat Irritable Bowel Syndrome (IBS) by examining connections between the brain, gut, and gut bacteria. Researchers aim to determine if CBT can alter brain-gut communication and whether these changes vary between men and women. Participants will either receive CBT sessions on their phones or continue with their usual care routine. The trial seeks individuals with IBS symptoms who have no other significant health issues and are not currently using CBT. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on IBS treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that alter GI motility and gastric pH at least 72 hours before any physiologic test visit and during the baseline and treatment intervention. You will need approval from your primary care provider to stop these medications. Rescue medications like bisacodyl and loperamide are allowed during intervention periods but not during baseline or within 3 days of follow-up MRI.

What prior data suggests that Cognitive Behavioral Therapy is safe for IBS patients?

Research has shown that Cognitive Behavioral Therapy (CBT) is generally safe and well-tolerated. CBT, a type of talk therapy, helps people change negative thinking patterns and has been used successfully for various mental health issues, such as depression.

For IBS (Irritable Bowel Syndrome), CBT improves symptoms by addressing the interaction between the brain, gut, and microorganisms in the digestive system. No evidence indicates serious side effects from CBT, and most people tolerate this therapy well.

Since CBT does not involve drugs, it avoids the common side effects associated with medications, making it an attractive option for those concerned about medication side effects. Overall, CBT is considered a safe treatment choice for managing IBS symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for irritable bowel syndrome (IBS) because it offers a non-drug approach to managing symptoms. Unlike standard treatments like dietary changes, medications, or probiotics, CBT targets the psychological factors that can influence gut health, helping patients manage stress and anxiety that often exacerbate IBS symptoms. This approach can empower patients with coping strategies and potentially reduce reliance on medication, providing a holistic and sustainable option for managing their condition. Additionally, the treatment is delivered remotely, allowing flexibility and accessibility for patients who might struggle to attend in-person sessions.

What evidence suggests that Cognitive Behavioral Therapy is effective for IBS?

Studies have shown that Cognitive Behavioral Therapy (CBT) effectively treats Irritable Bowel Syndrome (IBS). In this trial, participants in the Cognitive Behavioral Treatment Arm will undergo 8-10 weeks of remote CBT. This therapy reduces IBS symptoms by changing negative thought patterns that can worsen these symptoms. Research indicates that CBT improves the quality of life for IBS patients by decreasing symptoms like stomach pain and discomfort. Notably, CBT focuses on the connection between the brain, digestive system, and gut bacteria. This therapy is particularly helpful as it manages both the emotional and physical symptoms of IBS, leading to a more balanced life. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-55 with IBS, meeting ROME IV criteria. Women must be premenopausal, not pregnant or breastfeeding, and willing to use non-hormonal birth control. Participants should have no major psychiatric diagnoses or significant medical conditions that could interfere with the study.

Inclusion Criteria

I am not pregnant or breastfeeding and haven't been for at least 6 months.

I will use non-hormonal birth control or avoid pregnancy during the study.

I use hormonal birth control and still have a monthly period.

Exclusion Criteria

I haven't taken antibiotics or probiotics within 3 months before joining the study.

My average abdominal pain is 3 or more on a scale of 0 to 10.

I haven't had cancer, except for treated skin cancer, in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

1 visit (in-person), 1 visit (virtual)

MRI and Baseline Assessment

Participants undergo MRI scanning and complete baseline assessments

1-3 weeks

1 visit (in-person)

Treatment

Participants receive 8-10 weeks of remote cognitive behavioral therapy

8-10 weeks

Weekly online sessions

Post-Treatment MRI

Participants return for a post-CBT MRI visit identical to the baseline assessment

2-3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy

Trial Overview

The effectiveness of Cognitive Behavioral Therapy (CBT) on IBS is being tested, focusing on sex differences in response. The study involves advanced neuroimaging and microbiome analysis before and after CBT to understand brain-gut-microbiome interactions.

How Is the Trial Designed?

Group I: Cognitive Behavioral Treatment Arm Experimental Treatment 1 Intervention

Subjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion.

Group II: Usual Care Arm Active Control 1 Intervention

Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks.

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

A psycho-educational intervention for 69 IBS patients led to significant improvements in gastrointestinal symptom severity, visceral sensitivity, depression, and quality of life, with benefits maintained at a 3-month follow-up.

The intervention was particularly effective for patients with low to moderate baseline quality of life, indicating that it can help change negative thoughts and fears about IBS symptoms, leading to meaningful symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: symptoms of the irritable bowel syndrome are improved by a psycho-education group intervention. Labus, J., Gupta, A., Gill, HK., et al.[2022]

In a study of 20 patients with irritable bowel syndrome (IBS), those who received intensive cognitive therapy showed significantly greater reductions in gastrointestinal symptoms compared to those who only monitored their symptoms, with a p-value of .005.

At the end of the treatment, 80% of the cognitive therapy group experienced clinically significant improvement, while only 10% of the symptom monitoring group did, and these benefits were maintained at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for irritable bowel syndrome. Greene, B., Blanchard, EB.[2019]

Cognitive Behavioral Therapy (CBT) has been shown to be an effective treatment for patients with refractory Irritable Bowel Syndrome (IBS), supported by multiple site trials in the UK and USA.

Despite its efficacy, CBT is often only available in specialized care settings, highlighting the need for improved access and delivery methods, such as digital therapeutics, to maximize its benefits for IBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills over pills? A clinical gastroenterologist's primer in cognitive behavioral therapy for irritable bowel syndrome. Lackner, JM.[2022]

Irritable bowel syndrome (IBS) symptoms are often linked to underlying emotional disorders like depression and anxiety, suggesting that a biopsychosocial approach is essential for effective treatment.

Psychotherapy and antidepressants are key components in managing IBS, with a focus on addressing emotional and psychosocial factors to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome. Toward a biopsychosocial systems understanding. Crouch, MA.[2005]

Psychological treatments, such as cognitive behavior therapy and hypnotherapy, have been shown to significantly improve symptoms of irritable bowel syndrome (IBS) and enhance mental health outcomes, as evidenced by a review of nearly 60 studies.

The review highlights the importance of addressing the psychological aspects of IBS, including anxiety and depression, and suggests that future research should explore the effectiveness of mind-body therapies like mindfulness-based stress reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Irritable bowel syndrome: comorbid psychiatric disorders and psychological treatment options]. Gajdos, P., Rigó, A.[2019]

In a systematic review of 19 randomized controlled trials involving 2188 participants, 10% of those undergoing cognitive behavior therapy (CBT) for health anxiety reported adverse events, and 17% dropped out of the treatment, indicating that while CBT is effective, it can have unwanted outcomes.

In a secondary study of 336 participants, 17% reported adverse events, and 0-10% experienced overall symptom deterioration, suggesting that while CBT is generally effective, there is variability in individual experiences and a need for strategies to minimize dropouts and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unwanted outcomes in cognitive behavior therapy for pathological health anxiety: a systematic review and a secondary original study of two randomized controlled trials. Axelsson, E., Hedman-Lagerlöf, E.[2023]

An 8-week mindfulness-based cognitive therapy (MBCT) program is being tested for its effectiveness in improving mindfulness skills and reducing self-harm behaviors in patients with borderline personality disorder (BPD) who engage in non-suicidal self-injury (NSSI).

The study will involve 60 BPD patients and aims to demonstrate that MBCT is more effective than waiting list or supportive therapy in enhancing emotion and impulse control, which are critical for managing BPD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Borderline personality disorder and non-suicidal self-injury: the role of mindfulness training in risk reduction]. Kresznerits, S., Zinner-Gérecz, Á., Perczel-Forintos, D.[2023]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Mindfulness-based cognitive therapy (MBCT) is effective for preventing relapse in recurrent depression, showing efficacy comparable to maintenance antidepressants, based on several randomized controlled trials.

Preliminary studies suggest that MBCT may also be beneficial for treating active depression, including treatment-resistant cases, as well as in bipolar disorder and anxiety disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy: theory and practice. Sipe, WE., Eisendrath, SJ.[2018]

Cognitive behavior therapy (CBT) was effective in reducing anxiety and improving symptoms in a chronic case of Irritable Bowel Syndrome (IBS), highlighting its potential as a psychological intervention.

The study suggests that psychological interventions like CBT can enhance the quality of life and psychosocial functioning for individuals suffering from IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irritable bowel syndrome and its psychological management. Tripathi, R., Mehrotra, S.[2020]

There is currently no single therapy that effectively treats all symptoms of Irritable Bowel Syndrome (IBS), highlighting the complexity of the condition.

A combination of various treatments, including medication, lifestyle changes, and psychotherapies, is often necessary to provide symptom relief tailored to individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The general aspects of the treatment of irritable bowel syndrome]. Iwai, A., Miyahara, T., Koyama, H., et al.[2011]

Mindfulness-based cognitive therapy (MBCT) adapted for combat PTSD showed significant improvement in PTSD symptoms compared to treatment-as-usual, with a notable reduction in avoidance symptoms and PTSD-related negative cognitions.

The study involved 37 participants (20 in the MBCT group and 17 in the TAU group) over an 8-week period, and 75% of MBCT completers demonstrated good compliance and clinically meaningful improvements in their PTSD assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of group mindfulness-based cognitive therapy (MBCT) for combat veterans with posttraumatic stress disorder (PTSD). King, AP., Erickson, TM., Giardino, ND., et al.[2022]

The study presents a behavior analysis and treatment plan for a patient with chronic irritable bowel syndrome (IBS), highlighting the potential benefits of this approach for patients who have not responded well to traditional treatments.

The findings suggest that behavior analysis may offer a valuable alternative for managing IBS in patients with poor treatment prognosis, although specific outcomes and methods are not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for irritable bowel syndrome. A case report. Garrick, TR.[2019]

In a study of 34 patients with irritable bowel syndrome, individualized cognitive treatment (CT) led to significantly greater reductions in gastrointestinal symptoms compared to self-help support groups and a waiting-list control over an 8-week period.

CT also resulted in notable improvements in psychological measures of depression and anxiety, with these benefits maintained and even enhanced at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. Payne, A., Blanchard, EB.[2022]

Telephone-based CBT (TCBT) and web-based CBT (WCBT) for refractory irritable bowel syndrome (IBS) were well-received by participants, who appreciated the flexibility and support from therapists, leading to lasting positive impacts on their understanding of IBS and improvements in symptoms and quality of life.

Despite some initial skepticism and challenges in maintaining motivation, participants reported significant benefits from both forms of CBT, suggesting these methods could enhance access to effective treatment for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Telephone-Based and Web-Based Cognitive Behavioral Therapy for Irritable Bowel Syndrome: Longitudinal Qualitative Study. Hughes, S., Sibelli, A., Everitt, HA., et al.[2021]

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